Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472206
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Community Health Workers And MHealth to ImProve Viral Suppression Plus CHAMPS
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Community Health Workers And MHealth to ImProve Viral Suppression Plus CHAMPS
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMPS
Brief Summary:
Although global efforts have been made to end the HIV epidemic there are still some gaps in HIV testing antiretroviral therapy ART adherence and viral suppression VS among people with HIV PWH These gaps are particularly prominent in the Deep South of the United States US where PWH face challenges in accessing healthcare services In response a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression CHAMPS intervention This intervention uses mobile health mHealth technology and a team of community health workers CHW to design an intervention to improve ART adherence and VS The CHAMPS intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission The study will engage the participants by developing culturally relevant materials and retention strategies evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings and assessing regionalized implementation factors Ultimately the study will test the effectiveness of CHAMPS on ART adherence and viral load suppression for PWH in Alabama Louisiana and Mississippi
Detailed Description:
Despite efforts to achieve UNAIDS 95-95-95 targets marked deficits remain in HIV testing antiretroviral therapy ART adherence and viral suppression VS among a growing number of persons with HIV PWH Gaps in HIV treatment success are particularly pronounced in the United States US Deep South These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented further exacerbating the challenges inherent in the lives of underserved marginalized groups such as PWH In this way the development and evaluation of interventions using a resource-savvy cadre of community health workers CHW holds promise for addressing these challenges Yet gaps exist in the CHW literature and research is needed to bring CHW interventions to scale to ameliorate the large gaps in the US HIV Care Continuum particularly in Ending the HIV Epidemic EHE priority locations
In response the study team has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression CHAMPS intervention which leverages mobile health mHealth technology to create a multi-component intervention that targets multiple levels individual social and sexual networks and community to improve ART adherence and VS The study team will build on the strong preliminary data of extant intervention work in PWH by leveraging the CHAMPS intervention which will be delivered by personnel from four HIV care settings in the Deep South The CHAMPS intervention is delivered via an mHealth platform to support PWH to self-manage their ART regimens and adds to the extant CHAMPS intervention by adding a CHW-delivered supportive risk reduction counseling sexual behavior and substance use during periods of non-suppression to prevent HIV transmission This study also builds upon mChoice U01PS005229 and WiseApp R01HS025071 studies to improve ART adherence and VS in the Deep South This study design has a three-fold purpose of 1 engaging the target population in the development of culturally relevant recruitment materials and retention strategies for the study 2 assessing the clinical effectiveness and sustainability of the intervention in Deep South settings and 3 evaluating regionalized implementation factors guided by the Reach Effectiveness Adoption Implementation and Maintenance framework Ultimately this study will test CHAMPS to promote ART adherence and suppressed viral load for PWH in in Alabama Louisiana Orleans Parish and Mississippi US EHE prioritized jurisdictions Importantly the multi-component intervention targets multiple levels to address HIV risk behaviors during periods of non-suppression--an innovative and impactful component likely to be of great public health import
In response the study team has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression CHAMPS intervention which leverages mobile health mHealth technology to create a multi-component intervention that targets multiple levels individual social and sexual networks and community to improve ART adherence and VS The study team will build on the strong preliminary data of extant intervention work in PWH by leveraging the CHAMPS intervention which will be delivered by personnel from four HIV care settings in the Deep South The CHAMPS intervention is delivered via an mHealth platform to support PWH to self-manage their ART regimens and adds to the extant CHAMPS intervention by adding a CHW-delivered supportive risk reduction counseling sexual behavior and substance use during periods of non-suppression to prevent HIV transmission This study also builds upon mChoice U01PS005229 and WiseApp R01HS025071 studies to improve ART adherence and VS in the Deep South This study design has a three-fold purpose of 1 engaging the target population in the development of culturally relevant recruitment materials and retention strategies for the study 2 assessing the clinical effectiveness and sustainability of the intervention in Deep South settings and 3 evaluating regionalized implementation factors guided by the Reach Effectiveness Adoption Implementation and Maintenance framework Ultimately this study will test CHAMPS to promote ART adherence and suppressed viral load for PWH in in Alabama Louisiana Orleans Parish and Mississippi US EHE prioritized jurisdictions Importantly the multi-component intervention targets multiple levels to address HIV risk behaviors during periods of non-suppression--an innovative and impactful component likely to be of great public health import
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MD019184 | NIH | None | None |